Professional Documents
Culture Documents
Revision:
Version:
File:
8
26 October 2009
[AD3001_E00R08.doc]
Users Manual
WARNING: The information that is printed within this manual is vital for the correct use of the
equipment; please read it carefully before use.
Technix S.p.A.
[File: AD3001_E00.doc]
Technix S.p.A.
TABLE OF CONTENTS
1.
2.
COMPONENT IDENTIFICATION................................................................................................. 6
2.1.
Overview............................................................................................................................. 6
2.2.
Collimator ........................................................................................................................... 6
2.3.
Control panel ...................................................................................................................... 7
2.4.
Audible signals..................................................................................................................... 8
2.5.
Signals and error messages................................................................................................... 9
3.
4.
FUNCTIONING ....................................................................................................................... 12
4.1.
Transport........................................................................................................................... 12
4.2.
Positioning......................................................................................................................... 13
4.3.
Collimator adjustment ........................................................................................................ 14
4.4.
Start up and checks at the ignition ....................................................................................... 15
4.5.
Exposures .......................................................................................................................... 16
4.5.1. Operative procedure ........................................................................................................ 16
4.5.2. Programs for the Anatomical programming mode (APR MODE)........................................... 17
4.5.3. Perform an exposure......................................................................................................... 18
4.5.4. Useful information ............................................................................................................ 19
4.5.5. Optional: dosimeter (DAPmeter)........................................................................................ 19
4.5.6. Optional: Radiography with examination table and Potter Bucky grid ................................... 20
4.6.
Shutdown procedure .......................................................................................................... 20
5.
MAINTENANCE ....................................................................................................................... 21
5.1.
General Warnings.............................................................................................................. 21
5.2.
Checks and inspection by the user ....................................................................................... 21
5.3.
Cleaning ........................................................................................................................... 22
5.4.
Disinfection........................................................................................................................ 22
6.
TECHNICAL DATA.................................................................................................................... 23
6.1.
Electrical data .................................................................................................................... 23
6.2.
Functioning features ........................................................................................................... 23
6.3.
Radiological data............................................................................................................... 24
6.4.
Environmental data ............................................................................................................ 25
6.5.
Mechanical data ................................................................................................................ 25
6.5.1. Unit sizes.......................................................................................................................... 26
6.6.
Components specifications.................................................................................................. 27
6.6.1. Generator ........................................................................................................................ 27
6.6.2. Tube-Housing Assembly .................................................................................................... 28
6.6.3. Collimator ........................................................................................................................ 30
6.6.4. DAP meter (dose-area product meter) (optional)................................................................. 30
6.6.5. Printer for DAP (optional)................................................................................................... 30
6.7.
Accessories and options...................................................................................................... 31
6.8.
Compliance with Directives and Technical Standards ............................................................ 31
6.9.
Labels and symbols ............................................................................................................ 31
6.9.1. Internal symbols................................................................................................................ 33
6.9.2. Various symbols................................................................................................................ 33
6.9.3. Packing label.................................................................................................................... 33
DOCUMENT STATUS........................................................................................................................... I
.
[File: AD3001_E00.doc]
1.
Technix S.p.A.
This x-ray unit must be used in strict compliance with the safety instructions contained in this
manual and must not be used for purposes other those for which it was intended
The x-ray unit may only be operated by skilled, properly trained personnel with the required
knowledge of x-ray safety practices and the proper use of x-ray equipment.
The operator is responsible for the use of the system in compliance with the applicable standards concerning
installation and use.
The unit must not be operated when electrical, mechanical, or radiological faults are present
or when any of the indicators or alarm devices are malfunctioning.
When used in conjunction with other apparatus, components, or modules, whose
compatibility is uncertain, it is necessary to ensure the absence of any danger to the patient
or operator. Consult Technix S.p.A. for information.
Technix S.p.A. is responsible for the safety of its products only when maintenance, repairs, or
modifications have been performed by Technix S.p.A. or by personnel authorized by Technix
S.p.A. in writing.
As with any technical apparatus, this x-ray unit must be used properly with periodic checks
and maintenance as specified in the chapter Programmed maintenance.
The system safety circuits and devices must not, for any reason, be moved, modified, or
omitted.
Technix S.p.A. cannot be held liable for any malfunction, damage, or danger resulting from improper use of
the system or non-compliance with the rules for proper maintenance.
1.1.
Electrical safety
1.2.
Only trained service personnel authorized by Technix S.p.A. may remove the unit covers and
only in accordance with the instructions contained in the Service Manual.
This X-ray unit may only be used in environments or medical rooms in compliance with the
applicable IEC standards.
The X-ray unit must not be used in areas where there exists a danger of explosion.
Cleaning and disinfecting agents, including those used on patients, may create an explosive,
gaseous mixture. Use only those products in compliance with the applicable rules.
Mechanical safety
[File: AD3001_E00.doc]
Technix S.p.A.
1.3.
1.4.
When necessary, use protective shielding against radiation in addition to the shielding already provided
on the unit.
Use protective aprons containing a material equivalent to 0,35mm of lead. Material of this nature
reduces radiation at 50kV by 99,95% and at 100kV by 94,5%.
The best protection against radiation is distance. It is therefore recommended that you stay as far as
possible from the x-ray source and the exposure target. For this purpose, use all of the cable length
provided for the foot-switch.
Avoid walking or standing directly in the x-ray beam.
Always use the smallest possible field of exposure by closing properly the collimator diaphragms. The
scatter dose produced depends principally on the volume of the irradiated object.
Never modify or disconnect the safety circuits or devices designed to prevent accidental
exposures.
[File: AD3001_E00.doc]
1.5.
Technix S.p.A.
General disposal
Technix S.p.A. produces radiological systems that are advanced in terms of safety and environmental
protection. Assuming that the unit is properly used, there is no risk to people or the environment.
In order to comply with applicable safety requirements, it is necessary to use materials that may be harmful to
the environment (for example: monobloc oil, protective lead, boards and electronic components). Therefore,
where necessary, proper disposal methods, according to the regulations of the country where the unit is
installed, should be followed.
For this reason, the unit may not be disposed of along with industrial or domestic waste and
must be regarded as hazardous waste.
This symbol indicates that the wastes resulting from the electric and electronic units have not to
be disposed as undifferentiated town wastes and they have to be picked up separately.
The proper differentiated collection for the following start of the unit disused to the recycle,
treatment and disposal, compatible with the environment, aid to prevent possible negative
effects on the environment and health and it favours the recycle of materials that compose the
unit.
The abusive disposal of the product from the user implies the application of administrative
sanctions according to the Standards in force of the unit installation country.
For information concerning the dismantling modes of the units out of use, stick to the local
provisions or contact an representative authorized by the manufacturer.
For additional information, contact Technix S.p.A.
1.6.
Operating theater
Sport medicine
Plaster room
First aid
Pediatrics
Orthopaedics
This x-ray unit must not be used in areas where danger of explosion exists.
[File: AD3001_E00.doc]
Technix S.p.A.
1.7.
Interfaceability
The device does not foresee any interaction with medicines; instead it's possible to apply to the unit the
ionization chamber dosimeter as optional (mod. DIAMENTOR PX). It complies with the safety requirements
foreseen by the 93/42/EEC Directive. However, the liability of the interface, if it has not been evaluated and
authorized by Technix S.p.A. in writing, is of the operator and/or the person who has performed the interface.
1.8.
Classification
Protection against electrical hazards .................. Class I
Protection against direct and indirect contact ..... Unit, Type B with Type B applied part
Protection against water penetration.................. Common protection (IPXO)
Use condition protection................................... Continuous use with intermittent load
1.9.
Compliance
This x-ray unit is in compliance with the electromedical devices Directive 93/42 EEC and with the other
national and international standards in force.
Information concerning the compliance can be required to Technix S.p.A.
The manufacturer (according to the European Directive 93/42/EEC) of the unit TMS300 is:
Technix S.p.A.
Via E. Fermi, 45
24050 Grassobbio, BG - ITALY
Tel: +39 035 38 466 11
Fax: +39 035 33 56 75
1.10.
Copyright
The original release of this manual is in Italian language (file: AD3001_E00RXX.doc). For further information,
please refer to the Italian version.
The software contained in the unit belongs to Technix S.p.A. Upon receipt of the unit, the user acquires the
right to use the software in combination with the unit. This right is neither exclusive nor transferable.
Written authorization to Technix S.p.A. is mandatory prior to any modifications for the unit use with functions
other than the ones foreseen.
[File: AD3001_E00.doc]
Technix S.p.A.
2.
COMPONENT IDENTIFICATION
2.1.
Overview
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
Monobloc
Goniometer
Monobloc handle
Collimator
Supply cable-winding
Equipotential node
Connector for Potter
X-ray handswitch
Foot brake
Cassette holder
Magneto-thermic switch
12.
13.
14.
15.
16.
17.
18.
19.
20.
21.
22.
23.
Supply cable
Handle for unit movement
Control panel
Arm safety lock for transport
Monobloc support arm
Safety lock for monobloc rotation
Selector of HAND-SWITCH CORDLESS mode
IR receiver (optional)
X-ray remote control (optional)
Printer for Dose Meter (optional)
Hook for radio protective apron (optional)
Tilting pedal (optional)
Figure 1
2.2.
Collimator
1.
2.
3.
Longitudinal collimation
Extensible meter for focus-skin distance check.
Transversal collimation
4.
5.
1
3
5
Figure 2
Pag. 6/34- Rev.6
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Technix S.p.A.
2.3.
Control panel
Figure 3
Here is a brief description of the keys function in standard use and the signals meaning.
OFF
Unit OFF.
ON
Unit ON, the green led indicates that the unit is connected to the
mains and supplied.
POTTER
COLLIMATOR
SMALL FOCUS
Small focus selection. The lit led indicates that the selection has
been done.
LARGE FOCUS
Large focus selection. The lit led indicates that the selection has
been done.
DOSE
MENU
[File: AD3001_E00.doc]
Technix S.p.A.
kV+ kV-
mAs+ mAs-
RESET
F#
2.4.
To modify KV value
READY
X-RAY
Audible signals
Here is the list of the most important audible signals:
2 BEEPS
Storage ok
3 BEEPS
Exposure ok
A LONG BEEP
Alarm, malfunction
[File: AD3001_E00.doc]
Technix S.p.A.
2.5.
Warnings
Errors
Fatal Errors
(WARN)
(ERR)
(FERR)
Warnings (WARN)
When this alarm appears, after taking the proper precautions, it is enough to press RESET on the control
panel to go on to work with the same modes set. In order to interpret the alarm, refer to the tables indicated
successively.
Errors (ERR)
When this alarm appears, after taking the proper precautions, it is enough to press RESET on the control
panel to go on to work with the same modes set. In order to interpret the alarm, refer to the tables indicated
successively. This type of alarm always leaves a trace, in fact the unit stores information about the error (date,
time, kV and mAs) so that the service intervention is made easier.
Fatal Error (FERR)
This alarm does not allow operations to continue on the unit. Its necessary to switch the unit OFF. This type
of alarm always leaves a trace, in fact the unit stores information about the error (date, time, kV and mAs) so
that the service intervention is made easier.
For the unit operator
Every signal is displayed and appears in the language according to the unit configuration (ITA, ENG,
FRE, GER, SPA, POR)
WARNING SIGNAL
ERR o r
MANUA L
6 3
WA R N
FATAL
ERROR
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3.
Technix S.p.A.
W = alarm
S = unit status
Text
READY
BUSY
MANUAL
CLOCK OFF
POWER FAULT
V3 FAULT
W
W
RESET APR
APR OUT OF RANGE
TUBE SEASONING
FILAMENT
HOT TUBE
V2 FAULT
STARTER INTERLOCK
CHOPPER FAULT
TIME OUT
LACK OF X-RAY
MAX TIME
DATA ERR.
MAN STOP XR
INVERTER KV ERROR
F
F
F
INVERTER OVERLOAD
INVERTER FAULT
TUBE CALIB. ERR.
DAP INACTIVE
MAX DOSE
S
W
Dosimeter
S
S
S
W
DAP READY
DAP ERROR
DAP RESET
PLUG A BUCKY
EXT XR ORDER
Meaning
The unit is ready to perform an exposure
Preparation phase
System clock error
[File: AD3001_E00.doc]
Action
Wait for READY message
Press RESET to proceed
Turn off, wait for some minutes, turn on
and if the error appears again, call
Service
Turn off, wait for some minutes, turn on
and if the error appears again, call
Service
Press RESET to proceed
Set differently the parameters
Technix S.p.A.
The table below shows all the messages and signals in the five languages that can be set.
English (GB)
Italian (I)
French (F)
German (D)
Spanish (ES)
Portuguese (PT)
ENG
ITA
FRE
SPA
POR
CLOCK OFF
ERR.OROLOGIO
ERR. HORLOGE
FALLO RELOJ
ERRO RELOGIO
POWER FAULT
POTENZA GUASTA
ERR. BATTERIE
FALLO ACUMUL.
POTENCIA FALHA
V3 FAULT
ERRORE V3
V3 DEFECT.
FALLO V3
ERRO V3
RESET APR
INI.APR
INI.APR
GER
TAKTGEBER
DEFEKT
STROMVERSORG.
DEF
V3 DEFEKT
APR-DATEN
DEFEKT
INI.APR
INI.APR
APR OUT OF
RANGE
ERRORE IN APR
ERREUR APR
APR-WERT FALSCH
FALLO APR
ERRO APR
TUBE SEASONING
FORM.DEL TUBO
FORM. DU TUBE
FILAMENT
HOT TUBE
V2 FAULT
STARTER
INTERLOCK
TIME OUT
READY
BUSY
FILAMENTO
TUBO CALDO
ERRORE V2
STARTER
BLOCCATO
CHOPPER
GUASTO
TEMPO SCADUTO
PRONTO
ATTESA
FILAMENT
TUBE CHAUD
ERREUR V2
BLOCAGE
DEMARREUR
HACHEUR
DEFECT.
TEMPS EXPIRE
PRET
ATTENDRE
LACK OF X-RAY
ERRORE RAGGI
MAX TIME
DATA ERR.
TEMPO MAX
ERR. DATI
MAN STOP XR
STOP MANUALE
INVERTER KV ERR.
ERR.KV INVERTER
INVERTER
OVERLOAD
SOVRACCARICO
INV.
INVERTER FAULT
ERRORE INVERTER
ERR. CALIB.TUBO
MANUAL
HAND SWITCH
ERR
DAP READY
DAP INACTIVE
DAP Reset
DAP ERROR
MAXDOSE
PLUG A BUCKY
EXT XR ORDER
MANUALE
PREP ZU LANG
BEREIT
WARTEN
KEINE
ERREUR RX
STRAHLUNG
TEMPS MAX
MAX EXP ERREICHT
ERR. DONNE
DATEN-FEHLER
EXP
ARRT UTILISAT.
UNTERBROCHEN
WANDLER KV
ERR.KV CONVERT.
FEHLER
SURCHARGE
WANDLER
CONVERT.
UEBERLAST
DEFAUT
WANDLER FEHLER
CONVERT.
ROEHRE
ERR. CALIBRAGE
KALIBRIER.
MANUEL
MANUELL
ERR.PULSANTE RX
CHOPPER FAULT
DAP PRONTO
DAP INATTIVO
DAP AZZERATO
DAP ERRORE
MAXDOSE
COLLEGA BUCKY
NO RX ESTERNO
DAP PRET
DAP INACTIF
DAP a zero
DAP ERREUR
MAXDOSE
RELIER BUCKY
EXT XR ORDRE
ROEHRE
ENFAHREN
HEIZKREIS-FEHLER
ROEHRE HEISS
V2 DEFEKT
ANLAUF-FEHLER
CHOPPER-FEHLER
DAP BEREIT
DAP INAKTIV
DAP auf Null
DAP FEHLER
MAXDOSE
VERBINDEN
AUENAMTRIEB
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FILAMENTO
TEMPER.
FALLO V2
BLOQUEO
CEBADOR
FORMACAO
TUBO
FILAMENTO
TUBO MORNO
ERRO V2
STARTER
OBSTRUIDO
FALLO PULSADOR
ERRO CHOPPER
FUERA TIEMPO
LISTO
ESPERA
FORA TEMPO
PRONTO
ATENDIDO
SIN RADIACION
ERRO RAIOS
TIEMPO MAX
FALLO DATO
INTERRUP.
MANUAL
TEMPO MAXIMO
ERRO DADOS
TERMINO
MANUAL
FALLO KV TRANSF
ERRO KV INVERTER
SOBRECARGA
TRANSF
SOBRECARGA INV.
FALLO TRANSF
ERRO INVERTER
FALLO CALIB.
ERRO CALIB.TUBO
MANUAL
MANUAL
FALLO MANDO
ERRO BOTAO RX
DAP LISTO
DAP INACTIVO
DAP en cero
DAP ERROR
MAXDOSE
CONECT.BUCKY
NO BUCKY
DAP PRONTO
DAP NAO ATIVO
DAP ZERADO
DAP ERRO
MAXDOSE
LIGAR. BUCKY
NO RX FORA
Technix S.p.A.
4.
FUNCTIONING
4.1.
Transport
For the transport of the unit, consider the following instructions:
The unit must be OFF, the supply plug must be removed from the socket outlet and the cable
wound. (See Par. 4.6 Shutdown procedure).
Place the monobloc - collimator group vertically and activate its rotation safety lock (see Figure 4).
Pull the safety knob and rotate it till it is taken out (see Figure 5).
Move downwards the arm by using the handles and by keeping in vertical position the monobloccollimator group; when the parking position is reached (see Figure 6) rotate and engage the safety
lock.
Release the parking brake (see Figure 7 and Figure 8)
Move the unit by using only the proper handles for the transport.
Don't move the unit on surfaces with inclination higher than 10.
In order to overcome obstacles, pull downwards the transport handle and, at the same time, pull
the handle placed on the column.
In presence of the pedal for tilting (available as accessory on request) press with the foot on the
pedal and, at the same time, pull the the handle placed on the column.
Figure 4
Movements of the monobloc collimator group
Figure 5
Safety knob
Figure 6
Parking position
Figure 7
Figure 8
[File: AD3001_E00.doc]
Technix S.p.A.
4.2.
Positioning
For positioning the unit the following instructions should be considered:
Don't move the unit when the brakes are activated. For the movements use the proper handles.
Pull the safety knob and turn it till it is taken out (see Figure 5).
For adjusting and positioning the arm height use the handle on the monobloc. (see Figure 8).
Position the monobloc-collimator assembly over the relevant area of the patient (see Figure 10 Figure 11).
Turn the unit ON (see the paragraph 4.4 Start up and checks at the ignition)
Turn the collimator lamp ON (the lamp will stay on for about 30secs).
Collimate the x-ray beam to the dimension of the cassette (see the next paragraph)
If necessary, release the brake to perform this operation (don't forget to set it again!).
When positioning has been completed, lock all the movements and the parking brakes.
Figure 9
Figure 10
[File: AD3001_E00.doc]
Figure 11
4.3.
Technix S.p.A.
Collimator adjustment
1.
On the frontal panel of the collimator, there are two knobs for the beam adjustment (width and
length) as well as the push-button to turn ON the collimator lamp (see Figure 12). It is possible to turn
the lamp ON by pressing the COLLIMATOR push-button placed on the control panel.
Figure 12
The extensible meter allows to measure with accuracy the focus-film distance (FFD).
2.
Figure 13
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Technix S.p.A.
4.4.
2.
Connect the unit to the mains. Insert and turn the safety key in ON position (Fig.1 pos. 18), the
presence of the power supply voltage is indicated by the switching ON of the yellow led placed near
the ON key (Fig.3). If, with the plug inserted, the led is off, check that the automatic switch lever
(Fig.1 pos.11), placed on the unit side, is up (ON position).
Turn the unit ON by pressing ON key (Fig.3), follow step by step the Start up phase and check its
performance by comparing it with the following one:
check of leds and beepers: all the leds of the keyboard turn ON and the beeper emits a
prolonged sound;
software version:
without dosimeter
UN I T NAME
VER X . XX . XX
with dosimeter
XXXXXXXX
UN I T NAME
VER X . XX . XX
DAP
Start Up: on the unit it is possible to set the radiological data, including the APR, but it is not possible to
perform an exposure till the writing READY appears on the display
BUSY
MANUA L
63
3.
When the Start up is finished, the writing READY will appear on the display, the unit is ready for
use.
RE A D Y
MANUA L
6 3
If it does not occur, it is probable that the unit is faulty or that there are some malfunctions, contact the
authorized service personnel.
[File: AD3001_E00.doc]
4.5.
Exposures
4.5.1.
Operative procedure
Technix S.p.A.
Set the exposure data by following the operative procedure here below.
IGNITION & START UP
MANUAL MODE
R E ADY
MANU A L
63
4
Upon ignition the unit is in MANUAL MODE
Press MENU to
proceed to APR
MODE
Press F2, F3 or F4 to
select the proper
program
2 / 4
Press F2 to return to
APR menu
PROGRAM DISPLAY
R EADY
P ED I A T R I CS
I n f a n t
L u n g 1 . 5 k g
60
0 . 4
1st line: reserved to messages
2nd line: selected group
3rd line: program name
4th line: radiological parameters (kV & mAs)
The modification of some x-ray parameters in
respect of the stored values is indicated by the
asterisk (*) placed near the program name (3rd
line).
In order to store the new values, it is necessary to
press F3 and, by holding it down, press the
MENU Key.
[File: AD3001_E00.doc]
Technix S.p.A.
4.5.2.
Folder
Part of Body
Thorax ap
Skull
Cervical Spine
Lumbar Spine ap
Abdomen ap
Pelvis ap
Shoulder ap
2/4
Clavicle
UPPER
Humerus/elbow
EXTREMITIES
Forearm
Wrist
Hand ap
1/4
SKULL /
ABDOMEN
kV
mAs
85
78
66
78
85
77
66
66
60
52
48
46
3.2
5.0
6.3
6.3
5.0
3.2
16.0
10.0
4.0
3.2
2.5
2.5
SC
[DIN] 1
200
400
400
400
400
400
200
200
200
200
200
200
Part of Body
kV
mAs SC [DIN]1
Hip/Femur
3/4
Knee
LOWER
EXTREMITIES Lower Leg
Ankle
Calcaneus
Foot
Thorax 1.0 Kg
4/4
Thorax 2.0 Kg
CHILDREN
Thorax 4.0 Kg
Added Filter
Thorax 6.0 Kg
1mmAl +
2
Thorax 8.0 Kg
0,2mmCu
Thorax 10 Kg
74
66
60
55
52
48
60
62
72
74
76
76
5.0
4.0
4.0
4.0
3.2
2.0
0.2
0.4
0.4
0.4
0.4
0.63
Cartella
400
200
200
200
200
200
400
400
400
400
400
400
Here is the list of the APR programs and groups names in the five settable languages.
APR Groups and Programs
English (GB)
Italian (I)
German (D)
French (F)
SKULL/ABDOMEN
CRANIO/ADDOME
CRANE/ABDOMEN
SCHDEL/ABDOMEN
Thorax ap
Skull
Cervical Spine
Lumbar Spine ap
Abdomen ap
Pelvis ap
UPPER EXTREMIT.
Shoulder ap
Clavicle
Humerus/elbow
Forearm
Wrist
Hand ap
LOWER EXTREMIT.
Hip/Femur
Knee
Lower Leg
Ankle
Calcaneus
Foot
CHILDREN
Thorax 1.0 Kg
Thorax 2.0 Kg
Thorax 4.0 Kg
Thorax 6.0 Kg
Thorax 8.0 Kg
Thorax 10 Kg
Torace ap
Cranio
Spina Dorsale
Spina Lombare
Addome ap
Bacino ap
ESTREMIT SUP.
Spalla ap
Clavicola
Omero/Gomito
Avambraccio
Polso
Mano ap
ESTREMIT INF.
Fianco/Femore
Ginocchio
Gamba inf.
Anca
Calcagno
Piede
BAMBINI
Torace 1.0 Kg
Torace 2.0 Kg
Torace 4.0 Kg
Torace 6.0 Kg
Torace 8.0 Kg
Torace 10 Kg
Thorax ap
Crane
Col.Cervical
Col.Lumbaire
Abdomen ap
Bassin ap
EXTREMITES SUP.
Epaule ap
Clavicule
Humerus/Coude
Bras inf.
Poignet
Main ap
EXTREMITES INF.
Hanche/Femur
Genou
Jamb inf.
Art.Tibio Tors.
Calcaneum
Pied
ENFANTS
Thorax 1.0 Kg
Thorax 2.0 Kg
Thorax 4.0 Kg
Thorax 6.0 Kg
Thorax 8.0 Kg
Thorax 10 Kg
Thorax ap
Schdel
HWS
LWS ap
Abdomen ap
Becken ap
OBERE EXTREMIT.
Schulter ap
Schluesselbein
OA/Ellenbogen
Unterarm
Handgelenk
Hand ap
UNTERE EXTREMIT.
Huefte/OS
Knie
US
Fussgelenk
Fersenbein
Fuss
KINDER
Thorax 1.0 Kg
Thorax 2.0 Kg
Thorax 4.0 Kg
Thorax 6.0 Kg
Thorax 8.0 Kg
Thorax 10 Kg
Spanish (ES)
CRNEO/
ABDOMEN
Trax ap
Crneo
Columna Cerv.
Columna Lumb.
Abdomen ap
Pelvis ap
EXTREM. SUPERIOR
Hombro
Clavcula
Hmero/Codo
Antebrazo
Mueca
Mano ap
EXTREM. INFERIOR
Cadera/Fmur
Rodilla
Tibia/Peron
Tobillo
Calcneo
Pie
NIOS
Trax 1.0 Kg
Trax 2.0 Kg
Trax 4.0 Kg
Trax 6.0 Kg
Trax 8.0 Kg
Trax 10 Kg
Portuguese (PT)
SKULL/ABDOMEN
Thorax ap
Skull
Espinho Dorsal
Espinho Lumbar
Abdomen
Pelvis
EXTREM.AVANCADA
Hombro
Clavicola
Omero/Cotovelo
Forearm
Pulso
Mao ap
EXTREM.INFERIOR
Flanco/Femore
Joelho
Pe' inferior
Hip
Salto
Pe'
CRIANCAS
Thorax 1.0 Kg
Thorax 2.0 Kg
Thorax 4.0 Kg
Thorax 6.0 Kg
Thorax 8.0 Kg
Thorax 10 Kg
1 SC is the sensitivity class. According to DIN 6867-10, a class 400 film/screen system (SC=400) can cover a sensitivity range
of Smin=320 DIN to Smax=560 DIN. From the derived dose value Ks the tolerance for S will be approx. 30%.
2 The filter combination of 1 mmAl + 0,1 mmCu is also permissible
[File: AD3001_E00.doc]
4.5.3.
Technix S.p.A.
Perform an exposure
TMS300 provides for two different modes to perform an exposure:
Before performing an exposure, make sure that all the necessary precautions against radiation
have been taken.
After a long idle period (3 months or more) it is very important to proceed with the X-RAY TUBE
SEASONING. It is necessary to avoid high voltage discharges that could be destructive for the Xray tube. The seasoning procedure is described in the Service Manual.
1 step prep
2 step rad
Figure 14
The x-ray handswitch activates both the x-ray preparation phase prep and the emission phase rad. The
Figure 14 shows how to operate the handswitch to activate the preparation and the emission phases. It is not
possible to activate the emission phase rad without preparation; however, it is possible to perform
preparation without activating the emission.
The most frequent alarms during the use of the x-ray handswitch are the following:
1.
2.
TIME OUT The x-ray handswitch has been pressed at the 1st step (preparation) for more than 15s. In
order to perform radiography, it is necessary to release the handswitch and repeat the procedure.
MAN STOP RX The x-ray handswitch has been released before the end of exposure. In this case, the
display will show the radiological data obtained. In order to repeat the exposure, it is necessary to press
RESET.
CORDLESS Mode
The x-ray infrared control has got two push-buttons, one
for the lighting-ON of the collimator lamp and one for
activating both the x-ray preparation phase prep and
the emission phase rad.
Lamp lighting-ON For lighting ON the collimator lamp
press the relative key, the lamp will light OFF after the
lighting-ON time of 30sec.
Preparation phase prep press and release the pushbutton prep + rad.
Emission phase rad Press twice the x-ray push- button
prep + rad within 15sec. and hold it down till the
exposure is finished. When the exposure has been
completed, the unit emits three beeps. Put the remote
control in its seat on the unit again.
[File: AD3001_E00.doc]
LAMP
LOW
BATT
PREP +
RAD
Technix S.p.A.
4.5.4.
Useful information
4.5.5.
Only if the display shows the writing READY and the READY led is ON, it is possible to
perform an exposure.
The 1st line of the display shows the use messages and the error signals.
The 4th line of the display shows the radiological parameters.
After every exposure, the 4th line shows the radiological parameters and, in the middle, the
exposure time.
While shifting from APR MODE (Anatomical programming) to the MANUAL MODE,
radiological parameters do not change.
0 00 0 . 0 0
READY
c G y cm2
The measures summation is the sum of all the dose-area products read by the chamber. By pressing
F1+RESET, the value resets.
dosei areai
i =1
n is the number of exposures performed after the last time that F1+RESET has been pressed.
In order to determine the correct Dose Area Product to which the patient has been exposed, it is necessary to
press F1+RESET between each patient.
The possible measuring range is included between 0000,00cGycm2 and 9999,99cGycm2. When the
measures summation exceeds 9999,99cGycm2, the message MAXDOSE will appear. The presence of this
message does not exclude the possibility to perform exposures.
Data printing
If the DAP meter is installed and works properly (dose shown on the display), by pressing the F4 key it is
possible to print the data concerning the dose released on a dedicated printer, available as accessory on
request.
The final printing relates the data concerning:
Datum
Name/Id................
Born on ...............
xxxx.xx cGycm2
Operator..............
Date
Description
Patients name (*)
Birth date of the patient (*)
Dose to which the patient has been exposed (0000.00 cGycm2)
Operators signature (*)
Date and time of the exam (format dd-mm-yy hh:mm)
(*) datum to be inserted by hand from the operator.
Connect the printer to the connector placed on the front of the unit; Switch ON the printer; press the F4 key,
on the display the Print writing appears.
For more details and / or explanations on the printer, refer to the Users Manual of the printer.
[File: AD3001_E00.doc]
4.5.6.
Technix S.p.A.
The examination table or the Potter Bucky that can be connected to the unit must be according
to the Medical Devices Directive EEC 93/42.
After positioning the cassette and the patient, follow these instructions:
1.
connect the Potter Bucky grid or the table for the examination to the socket outlet placed on the
frontal unit part;
2. press the push-button for the Potter Bucky selection, if the potter works properly the led of the key
turns on;
3. place monobloc and collimator, set the exposure field as shown previously;
4. lock the parking brake;
5. select manually the values of kV and mAs or in APR mode, by choosing the data about the
examination that you need to perform;
6. pick up the x-ray handswitch;
7. keep away at least 2m from the x-ray tube;
8. press and hold down the handswitch in "prep" position for the preparation (about 1.2s);
9. press the x-ray handswitch in "rad" position;
10. hold down the x-ray handswitch till the exposure time is finished. The end of the exposure is
indicated by three Beeps emitted by the audible signal of the unit.
Note: occasionally when the potter grid has been selected non consent to proceed may appear, in this case
check the connection.
Note: it is possible to press the x-ray handswitch fully ("rad" position) from the beginning. In this case the x-ray
exposure will be performed automatically after the preparation.
4.6.
Shutdown procedure
Ensure unit is switched off before removing the connector from the mains outlet
Turn the unit off by operating the OFF key located on the control panel
Disconnect the supply cable and wrap it on the proper support.
Place the unit in parking position (down, with mechanical brakes activated).
[File: AD3001_E00.doc]
Technix S.p.A.
5.
MAINTENANCE
Technix S.p.A. can supply, on request, a programmed maintenance plan to be performed on the unit.
5.1.
General Warnings
As with any medical device, this system requires:
proper use;
5.2.
If a faulty or malfunctioning unit is used, risks to the operators and patients can increase.
Daily:
Weekly:
Every 6 months:
Yearly:
[File: AD3001_E00.doc]
5.3.
Technix S.p.A.
Cleaning
Please take the following information into consideration before choosing a detergent:
To clean plastic surfaces, simply use water and soap, and nothing else. If other detergents are used (e.g.
with a high alcoholic content, or corrosive solvents, or abrasive detergents), the material will tend to
break or opacify.
To clean enameled parts and aluminium surfaces, simply rub them with a wet cloth and a delicate
detergent, after that rub them with a dry wool cloth.
As regards, chromium-plated surfaces, only rub them using dry wool clothes; do not use any detergent.
To clean the other surfaces of the equipment, never use highly alcoholic products, corrosive or abrasive
detergents and solvents
Before cleaning the unit, please take the following actions:
Turn off the unit and unplug the mains power supply cable.
Ensure that no liquid seeps into the unit, so as to avoid short-circuiting or corroding the electrical and
electromechanical parts.
5.4.
Disinfection
To disinfect the equipment its advisable to use a common liquid solution featuring an aldehyde base or
disinfectants featuring an ampholytic surface-active agent base (e.g. Tego 103, Korsolin).
Substitute disinfectants releasing chlorine or based on phenols are likely to weaken the materials, hence they
are much to be avoided. The same limitations apply to undiluted solutions featuring a high alcoholic content.
Do not use disinfectant spray; it might penetrate the system, and its safety would not be guaranteed any
longer (damages possibly affecting electrical and electromechanical parts, formation of flammable air
mixtures and vapor solutions).
In cases where there is a danger that disinfection products may form inflammable or explosive
gaseous mixtures, always ensure that such gases have dispersed before re-using the
equipment.
[File: AD3001_E00.doc]
Technix S.p.A.
6.
TECHNICAL DATA
6.1.
Electrical data
Description
Voltage
Data
115/230Vac 10% standard monophase with automatic unit prearrangement in
function of the mains (plug & play).
Frequency
50/60Hz standard
Absorbed current
Values of current absorbed by the unit in the different operative conditions and in
the two power supply values:
Operative condition
115 Vac / 50Hz 230 Vac / 50Hz
Charger On
5,5 AMAX
3,4AMAX
Stand By
0,87A
0,58A
Stand By + Collimator Lamp
2,3A
1,5A
Stand By + Charger On
5,1A
3,0A
Stand By + Collimator Lamp + Charger On
6,7A
3,8A
Preparation
4,3A
5,5A
Preparation + Collimator Lamp
5,5A
7,3A
X-ray emission + Collimator Lamp
3APK
3APK
Line compensation
Automatic
Line resistance
<1 @115/230Vac
Standard socket outlet
16A @230Vac
Isolation class
Class I with applied parts type B
Use conditions
Continuous functioning with intermitting load
The unit is not suitable to the use where danger of inflammable mixtures with air or nitrous oxide exists.
6.2.
Functioning features
Description
Users interface
Settable languages
Radiography control
Safeties
Data
Keyboard with LCD alphanumeric display, 4 lines X 20 characters for all the
operative parameters and messages of possible faulty status.
Service program for faults finding.
Microprocessor management.
Italian, English, French, German, Spanish, Portugus, through configuration
program
By handswitch with extendible cable. It is proposed the use of the last kV
value used in manual mode or APR.
Upon the ignition, the unit is in manual mode with default values.
Filament current
Monobloc temperature
Overload
Max kV or H.V. fault
Stored data check
Microcontroller auto test
[File: AD3001_E00.doc]
6.3.
Technix S.p.A.
Radiological data
Data
Working technique
APR technique
Exposure control
Dose
Small focus (IEC 60336)
Large focus (IEC 60336)
Generator power in DC current
Inverter frequency
Inverter frequency in high voltage
Max.ripple
Rise time
kV range
mA range @115/230Vac
mAs range @115/230Vac
Times range @115/230Vac
Use coefficient (duty cycle)
kV
40
50
60
70
80
90
100
110
120
125
Dati
2 points with kV and mAs setting
24 exams storage (4 folders each of 6 exams) available in
the 5 different selectable languages.
Constant kV and mA during all the exposure
A 50% reduction (LD)
0,8mm
1,3mm
30kW@100kV
20kHz
40kHz
<2% @100kV,
(100kV,100ms, 300mA)
<2ms @100kV
40 125kV in step of 1kV
50 300mA automatically associated to kV
0,2 220mAs steps with increases of 12,5%
0,002 2,2s
in function of the set mAs
1:40
mA values @115/230Vac
Small focus
Large focus
H.P.
L.P.
H.P.
L.P.
(t<100ms) (t>100ms) (t<100ms) (t>100ms)
200mA
100mA
200mA
200mA
200mA
100mA
250mA
200mA
190mA
95mA
300mA
190mA
180mA
90mA
300mA
180mA
170mA
85mA
300mA
170mA
160mA
80mA
300mA
160mA
150mA
75mA
300mA
150mA
130mA
65mA
260mA
130mA
115mA
55mA
220mA
110mA
110mA
50mA
200mA
100mA
[File: AD3001_E00.doc]
Technix S.p.A.
6.4.
Environmental data
Description
Temperature
Relative humidity
Pressure
6.5.
Normal use
From +10C to +40C
From 30% to 75% non condensing
From 700 to 1060hPa
Mechanical data
Description
Weight
Max. width
Length in transport position
Max. height in transport position
Max. height with the arm at the max. extension
Control panel height
Focus-floor distance
Arm rotation around the vertical axis
Monobloc rotation around the arm axis
Monobloc rotation around its axis
Max. height of the front unit leg
Cassette holder
Movement
Wheels diameter
Data
approx.185 Kg (408 Lb)
700mm (27,56in.)
1338mm (52,68in.)
1458mm (57,40in.)
2258mm (88,90in.)
1000mm (39,37in.)
456 2018mm (17,95 79,45in.)
n.a.
180
151 (+133 -18 in respect of the vertical axis)
105mm (4,13in.)
5 cassettes format 35 x 43cm (12x15in.)
Manual.
Double front swiveling wheel.
Parking brake
Handle for tilting (obstacles overcoming)
Rear:
wheel 250mm (9,84in.) width 50mm (1,97in.)
Front:
double wheel 80mm (3,15in.) width 22mm (0,87in.)
[File: AD3001_E00.doc]
6.5.1.
Technix S.p.A.
Unit sizes
Figure 15
[File: AD3001_E00.doc]
Technix S.p.A.
6.6.
Components specifications
6.6.1.
Generator
Description
Inverter
Working frequency
Power supply
Dimensions
Max. absorbed current
Technology
Safeties
Generator power in constant DC current (IEC 601-1)
Dati
IHF 2030
20kHz max
680Vdc max
240x210x140 mm
9,45x8,27x5,51 in.
75A
IGBT
overcurrent
overvoltage
IGBT driver fault
30kW
(300mA @ 100kV per 0.1s)
125kVp
<2%
<2 ms
300mA
[File: AD3001_E00.doc]
6.6.2.
Technix S.p.A.
Tube-Housing Assembly
X-Ray Tube
Description
Type
Nominal anode power (IEC 613, EN 60613)
Nominal foci size (IEC 336, EN 60336)
Speed of rotation
Anode diameter
Anode material
Anode angle
Min. inherent filtration (IEC 522)
Thermal anode capacity
Max. continuous anode dissipation
Max. anode cooling speed
Nominal high-voltage
Max. filament current
Data
X22 0.8/1.3
16kW/32kW
0.8mm 1.3 mm
2850 rpm @ 50Hz
64mm (2,52in.)
Tungsten
15
0.7mmAl eq.
80kJ (107kHU)
300W
22kJ/min (29.5kHU/min)
130kV
5.4A
Tube seasoning
After a long idle period (3 months or more), it is necessary to proceed to the X-RAY TUBE SEASONING. The
procedure and the tube seasoning modes are described in the Service Manual.
Dimensions
80
800 W
500 W
70
300 W
60
200 W
50
100 W
40
30
20
10
0
0
10
15
Figure 16
Figure 17
300
250
50 kV
60 kV
70 kV
80 kV
90 kV
100 kV
110 kV
120 kV
130 kV
200
150
100
50
0
0.01
0.1
10
350
600
500
400
300
200
100
0
0.01
0.1
Figure 19
Figure 18
50 kV
60 kV
70 kV
80 kV
90 kV
100 kV
110 kV
120 kV
130 kV
[File: AD3001_E00.doc]
10
Technix S.p.A.
Monobloc
Description
Monobloc
Weight
Dimensions
X-ray tube
Anode
External thermostat
Thermal monobloc capacity
Max continuous thermal dissipation of monobloc
Max. monobloc anode cooling speed
Total filtration
Leakage radiation
Loading, heating and cooling curves
H.V. transformer insulation
Dati
MHF 2030
20kg (44,09Lb)
320x140x255mm (12,60x5,51x10,04in.)
X22 0.8/1.3
Rotating (2850rpm at 50Hz)(3400rpm at 60Hz)
57
600kJ (800kHU)
55W
5,4kJ/min (7,2kHU/min)
1.1mm Al
<1mGy/h according to IEC 601-1-3
See the enclosed diagrams
Oil bath
Dimensions
Figure 20
Heating and cooling curves of monobloc
Stored energy (kJ) / Time (min)
Figure 21
[File: AD3001_E00.doc]
6.6.3.
Technix S.p.A.
Collimator
Description
Type, brand and model
Collimator
Light source
X-ray field
Luminous intensity
Contrast ratio
Measurement of focus-film distance
Rotation
Weight
Sizes
Accessories
Max protection against leaked radiation
(EN60601-1-3 par.29.204.3)
Indicator accuracy
(EN60601-1-3 par.29.202.8)
Inherent filtration
(EN60601-1-3 par.29.201.2/29.201.6)
Light field accuracy
(EN60601-1-3 par.29.202.9)
Classification EN60601-1 par.5
Protection against electrical hazards
Protection against direct and indirect contacts
Protection against water penetration
6.6.4.
Data
Manual with internal light source (Ralco R221)
Square field, multilayers
Halogen Lamp 12V 100W with timed switching-on at
approx. 30s
43x43cm (16,93x16,93in.) at 1m (39,37in.) DFF
160lux at 1m (39,37in.) DFF
4:1
Extractable meter
115
8,4kg (18,52Lb)
183x168x256mm (7,20x6,61x10,08in.)
Prearrangement to insert the dosimeter
125kV 4mA
It corresponds to the x-ray fields with tolerance lower than
2% of used FFD
2.0mmAl eq.
It corresponds to the x-ray fields with tolerance lower than
2% of the used FFD.
Class I
Unit with applied part Type B
Common protection (IPXO)
Data
Dosimeter with ionization chamber, PTW-Freiburg
DIAMENTOR CI-P
cGycm2
0,01cGycm2
0000,00 9999,99 cGycm2
118mm x 118mm (4,65x4,65in.)
Data
SPrint-S
Thermal line printing
203dpi
>50mm/sec (it depends on the printing typology and the
environment temperature)
58mm
57.5 1
48mm
RS-232
1824VDC / 0,6A
925mA
050C
-2070C, without paper roll
1085%, without condensation
1090%, without condensation, without paper roll
146 x 88 x 65mm
370gr (without paper roll
EN60950+A1+A2+A3+A4
[File: AD3001_E00.doc]
Technix S.p.A.
6.7.
6.8.
6.9.
Standard
Optional
Optional
Optional
Optional
Optional
Description
Medical Devices Directive (CE mark)
Medical devices safety
Electromagnetic compatibility
Protection against ionizing radiation
General requirements, tests and guidance for alarm systems in medical
electrical equipment and medical electrical systems
High voltage generators
Tube housing groups
X-ray tubes focus
Figure 22
[File: AD3001_E00.doc]
Technix S.p.A.
Reference Figure 22
[File: AD3001_E00.doc]
Technix S.p.A.
6.9.1.
Internal symbols
Dangerous voltage
Precautionary warning
6.9.2.
6.9.3.
Various symbols
Unit OFF
Unit Type B
Selection of
HAND SWITCH
CORDLESS
mode
Unit ON
Total filtration
Large focus
Ionizing radiation
Alternate voltage
Small focus
Packing label
It is stuck outside the packing with red writings on white background.
Fragile
[File: AD3001_E00.doc]
Technix S.p.A.
[File: AD3001_E00.doc]
Document status
DOCUMENT STATUS
Rev.
Date
Pages
Modification description
26.08.03
25-07-02
4-34
14-01-04
All
21.01.05
Document approval
Updated paragraph Applications & use destination
Updated units labels
General revision
Introduction of the x-ray remote control accessory.
Introduced position of WEEE label.
Introduced explanation note of the WEEE symbol
(+repaging).
Updating of the unit labels and symbols.
Updating of the monobloc and unit labels according to the
standards in force.
31.10.05
tutte
10/07/06
32
05/12/06
21/05/07
30, 31
26/10/09
5, 32
5, 6, 7, 8, 9,
Introduced the function of the half dose.
10, 11, 12, 16,
Introduced the new dose meter chamber, printer for
17, 19, 23, 24, 30 dosimeter, tilting pedal, portuguese language on the display.
[File: AD3001_E00R08.doc]
Pag. I/I